Details for New Drug Application (NDA): 090701
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NDA 090701 describes CEFTRIAXONE SODIUM, which is a drug marketed by Anda Repository and Hikma and is included in two NDAs. It is available from one supplier. Additional details are available on the CEFTRIAXONE SODIUM profile page.
The generic ingredient in CEFTRIAXONE SODIUM is ceftriaxone sodium. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
The generic ingredient in CEFTRIAXONE SODIUM is ceftriaxone sodium. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
Summary for 090701
| Tradename: | CEFTRIAXONE SODIUM |
| Applicant: | Hikma |
| Ingredient: | ceftriaxone sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090701
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFTRIAXONE SODIUM | ceftriaxone sodium | INJECTABLE;INJECTION | 090701 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9678 | 0143-9678-01 | 1 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (0143-9678-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10GM BASE/VIAL | ||||
| Approval Date: | Oct 4, 2017 | TE: | AP | RLD: | No | ||||
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